Phase III ALTU-135 CP Safety Trial (DIGEST CP)

Anthera Pharmaceuticals

Status and phase: Terminated; Phase 3

Conditions: Exocrine Pancreatic Insufficiency

Treatments: Drug: Liprotamase

Study type: Interventional

Funder types: Industry

Identifiers

NCT00500084

14294

I5L-MC-TCAD (Other Identifier)

810 (Other Identifier)

Details and patient eligibility

About

This is an open-label, single-arm clinical study investigating the long-term safety of ALTU-135 treatment in Chronic Pancreatitis (CP) patients with exocrine Pancreatic Insufficiency (PI).

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Females of childbearing potential must be willing to use birth control
• Fecal elastase levels < 100 micrograms per gram (µg/g) stool measured at screening
• Able to perform the testing and procedures required for the study, as judged by the investigator
• Diagnosis of chronic pancreatitis or status post pancreatectomy

Diagnosis of chronic pancreatitis is based upon at least one of the following:

• Endoscopic retrograde pancreatography, magnetic resonance cholangiopancreatography (MRCP) or endoscopic ultrasound demonstrating ductal changes consistent with chronic pancreatitis
• Abnormal Secretin Pancreatic Function test with a peak bicarbonate concentration < 75 milliequivalents per liter (mEq/L)
• Presence of pathognomic pancreatic calcifications
• Pathology proven chronic pancreatitis on surgical specimens

Exclusion criteria

• Pregnancy, breastfeeding or of childbearing potential and not willing to use methods of birth control during the study
• History of liver transplant
• Liver transaminases >3x Upper Limit Normal (ULN) or total bilirubin >1.5x ULN at screening or at Baseline (except for patients with Gilbert's Syndrome)
• Participation in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to screening
• Any condition that the investigator believes would interfere with the intent of this study or would make participation not in the best interest of the patient
• History of pancreatic cancer
• Diagnosis of cystic fibrosis
• Active alcohol or drug abuse
• Presence of any medical condition that is likely to preclude survival for 12 months
• Demonstrated unlikely to comply with protocol requirements or complete the study

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

Liprotamase

Experimental group

Description:

Liprotamase is a fixed combination of lipase (32,500 units), protease (25,000 units) and amylase (3,750 units) administered orally with each of three meals and two snacks daily for 12 months

Treatment:

Drug: Liprotamase